Recall of 5,000 hypodermic needles due to insufficient documentation supporting sterility claims. Affected products may not be sterile, risking infection during medical procedures.
Insufficient documentation to support product sterility claims.
International Medsurg is recalling 5,000 boxes of 30-gauge hypodermic needles because their sterility claims lack proper documentation. This could lead to infections if used in medical procedures without confirmed sterility.
The needles were manufactured without sufficient documentation to prove they are sterile. If used in medical procedures without confirmed sterility, they could cause infections.
Healthcare professionals and patients using these needles for medical procedures. Those with the specific lot numbers listed in the recall are most at risk.
Check for the product name 'Hypodermic Needle, 30 G X 0.5 in REG BEVEL, 100 per box' with the listed lot numbers (e.g., 12-6780-x, 12-6925-x).
Identify the specific lot numbers listed in the recall notice to confirm if your needles are affected.
The recall is due to insufficient documentation supporting the product's sterility claims, which could lead to infection risks during medical procedures.
Check the lot numbers on your needles against the list provided in the recall notice (e.g., 12-6780-x, 12-6925-x).
The recall does not specify a remedy, so you should check with the manufacturer or healthcare provider for guidance.
We’ve drafted a message you can send International Medsurg to request your refund or repair — edit it as you like.
Subject: Recall Z-2823-2017 — International Medsurg International Medsurg Hello, I own a International Medsurg that is covered by recall Z-2823-2017 from International Medsurg. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
